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Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066391
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.

Condition or disease Intervention/treatment Phase
Penile Cancer Drug: cisplatin Drug: irinotecan hydrochloride Procedure: neoadjuvant therapy Phase 2

Detailed Description:


  • Determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer.
  • Determine the objective response rate and duration of response in patients treated with this regimen.
  • Determine the acute side effects of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1-3 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not undergoing local treatment receive up to 8 courses. Patients planning to undergo surgery receive up to 4 courses.

Patients are followed every 8 weeks until disease progression and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 13-28 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma
Study Start Date : June 2003
Actual Primary Completion Date : January 2006

Primary Outcome Measures :
  1. Objective response rate measured by RECIST at 8 weeks after completion of study treatment

Secondary Outcome Measures :
  1. Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter
  2. Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed penile squamous cell carcinoma

    • Locally advanced or metastatic disease

      • T3, N1-2 OR T4, N3, M1
  • Measurable disease outside of any previously irradiated field
  • No clinical signs of brain metastases



  • 75 and under

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)
  • Transaminases no greater than 2.5 times ULN (5 times ULN in the presence of liver metastases)


  • Glomerular filtration rate at least 60 mL/min


  • No chronic diarrhea
  • No unresolved bowel obstruction
  • No chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)


  • No other prior or concurrent malignancy except adequately treated skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy for pain control


  • Not specified


  • No other concurrent experimental or anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066391

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U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Institut Gustave Roussy
Villejuif, France, F-94805
National Institute of Oncology
Budapest, Hungary, 1122
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Christine Theodore, MD Gustave Roussy, Cancer Campus, Grand Paris
Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00066391    
Other Study ID Numbers: EORTC-30992
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
penile squamous cell carcinoma
stage III penile cancer
stage IV penile cancer
Additional relevant MeSH terms:
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Penile Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Penile Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action